Kornimate/medical-research-clean huggingface dataset:
dna methylation dynamics underlying arterial remodeling in pah patients: cleopahtra clinical trial

Conditions: Pulmonary Arterial Hypertension; Pulmonary Arterial Remodeling

Summary: to identify epigenetic-sensitive modifications and novel biomarkers linked to pathogenesis of pulmonary arterial hypertension (pah), we will perform the first study analyzing differentially-methylated regions (dmrs) in circulating t cells (cd04+ and cd08+) isolated from peripheral blood of patients undergoing right heart catheterization. moreover, we will perform rna deep sequencing on lung tissue biopsies to validate if dna methylation signatures in circulating t cells could reflect perturbations of gene expression in lung tissues.

pulmonary arterial hypertension (pah) is characterized by remodeling of pulmonary arteries caused by an inbalance of proliferation/apoptosis rate within the vascular wall. this pathological phenotype seems to be triggered by different environmental stress and injury events such as increased inflammation, dna damage, and epigenetic deregulation. many immune cells are increased in pah, such as t and b lymphocytes. remarkably, t cells are essential players of adaptive immunity and may be relevant initiators ("initial hit") of vascular remodelling. we will perform the first multi-omics study to: 1) investigate dna methylome of circulating t cells isolated from peripheral blood of pah patients, 2) detect transcriptomic profiles of lung tissues, 3) to assess if dna methylation of distinct genomic regions in circulating t cells could reflect modifications of lung gene expression programs.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with world health organization (who) group i pah. * ≥ 18 years * documentation of the following hemodynamic parameters by right heart catheterization, performed at time of study enrolment: * mean pulmonary arterial pressure (mpap) \> 25 mmhg at rest or mpap \> 30 mm hg with exercise. * pulmonary arterial wedge pressure (pawp) ≤ 15 mm hg. * pulmonary vascular resistance (pvr) ≥ 240 dynes.sec.cm-5 (e.g., ≥ 3.0 wood units) exclusion criteria: * patients who meet the criteria for inclusion into who groups ii, iii, iv or v. * do not meet the required hemodynamic criteria for entry into the study. * patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.

Keywords: adaptive immunity dna methylome rna-sequencing network analysis
wavefront-guided lasik for correction of myopia

Conditions: Myopia

Summary: laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia. advances over the last decade have allowed lasik to also correct higher order wavefront aberrations. in low myopia, there seem to be a minor effect of such wavefront-guided treatment. however, it remains to be established whether there is a beneficial effect in higher degrees of myopia. the study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.


Eligibility criteria:
inclusion criteria: * age 20 to 50 years * no known ocular or systemic disease * not pregnant or breastfeeding * myopia between -6.0 and -10.0 diopters * astigmatism below 2.0 diopters * difference of less than 1.0 diopters in spherical equivalent between eyes * normal corneal topography * corneal thickness sufficient for planned treatment exclusion criteria: * patients that do not fulfill inclusion criteria * insufficient quality of ocular wavefront measurement
pharmacokinetics and pharmacodynamics of intravenous artesunate for severe malaria treatment

Conditions: Severe Malaria

Summary: intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome

the current first line treatment for severe malaria in uganda is intravenous quinine with artemisinin derivatives as an alternative. intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. it is generally well tolerated and safe. this study aims is to assess the pharmacokinetics, pharmacodynamics and safety of iv artesunate in treatment of severe malaria in adults admitted to mulago national referral and teaching hospital, uganda.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and above 2. with severe malaria according to the following ciriteria: 3. a positive blood smear for malaria with p. falciparum mono-infection with parasitemia \> 500 parasites/ul of blood 4. who according to the attending physician require parenteral treatment and admission for malaria 5. willing to participate in the study 6. who are or whose first degree parents/caretakers are able to provide written informed consent exclusion criteria: 1. patients with history of prior antimalarial use within the last 72 hours 2. pregnant women 3. patients with contraindications to taking the study drugs 4. patients taking known inhibitors or inducers of cytochrome p450 -

Keywords: severe malaria artesunate intravenous
model 20066 left ventricular (lv) lead study

Conditions: Heart Failure

Summary: heart failure is a progressive disease that decreases the pumping action of the heart. this may cause a backup of fluid in the heart and may result in heart beat changes. when there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. in certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (crt) may be prescribed. crt is similar to a pacemaker. it is placed (implanted) under the skin of the upper chest. crt is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. the purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).


Eligibility criteria:
inclusion criteria: * patient meets crt inclusion criteria as determined by local regulatory and/or hospital policy * patient has signed and dated the study-specific informed consent form * patient is 18 years of age or older * patient is expected to remain available for follow-ups at the investigational center * patient is willing and able to comply with protocol exclusion criteria: * patient has a previous complete atrial based biventricular crt system * patient has a previous lv lead implanted or previous implant attempt within 30 days of implant or ongoing adverse events from previous unsuccessful attempt * patient has known coronary venous vasculature that is inadequate for lead placement * patient has unstable angina pectoris or has had an acute myocardial infarction (mi) within the past month * patient has had a coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) within the past three months * patient has chronic (permanent) atrial arrhythmias * patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) * patient has had a heart transplant (patients waiting for heart transplants are allowed in the study) * patient is enrolled in any concurrent drug and/or device study that may confound the results of this study * patient has a terminal illness and is not expected to survive more than three months * patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc). * patient is unable to tolerate an urgent thoracotomy
pulse pressure variation in spontaneously breathing patients

Conditions: Pulse Pressure Variation; Spontaneously Breathing

Summary: the investigators hypothesized that pulse pressure variation (ppv) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

pulse pressure variation (ppv) is known to be a dynamic indicator to predict fluid responsiveness in mechanically ventilating patients. ppv is generated by cardiopulmonary interaction with respiratory cycles. in spontaneous breathing, the cardiopulmonary interaction may lead to ppv by inverted manner. in this study, the investigators will evaluate the ability of ppv to predict fluid responsiveness in spontaneously breathing patients. before induction of anesthesia, radial artery cannulation is performed, and flotrac/vigileo (edwards lifesciences corp., irvine, usa) system is connected. and then, the investigators will measure baseline data including invasive blood pressure, pulse pressure, cardiac index, stroke volume variation in two different conditions: during tidal spontaneous breathing and during forced spontaneous breathing. all hemodynamic measurement will be repeated after infusion of fluid using 6ml/kg of hydroxyethyl starch solution (voluven), and will be averaged over 3 minutes. patients whose cardiac index increased by \>15% to fluid infusion is defined as responders. the investigators will compare the hemodynamic parameters between responders and non-responders. to evaluate the ability to predict volume responsiveness, receiver operating characteristics curves of the ppv will be calculated.

Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery exclusion criteria: * preoperative arrhythmia * left ventricular ejection fraction \<40% * intra-cardiac valve disease * intra-cardiac shunt * pulmonary artery hypertension * severe peripheral vascular obstructive disease * decreased pulmonary function
comparison of immunosuppression on progression of arteriosclerosis in renal transplantation

Conditions: Renal Transplantation

Summary: to compare in a prospective randomised way the effect of two different immunosuppressive regimens - mtor-based regimen or cni-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.


Eligibility criteria:
inclusion criteria: * age between 18-75 yr * willingness to provide written informed consent * ability to understand the study procedures exclusion criteria: * life expectancy \< 3 months * claustrophobia * allergy to iodinated contrast * treatment incompliance * pregnancy * highly hla-sensitized patients * severe dyslipidemia or proteinuria * severe leucopenia or thrombocytopenia * gfr \< 30 ml/min
evaluation of posterior capsule opacification in eyes with diabetes mellitus

Conditions: Development of Posterior Capsule Opacification

Summary: to compare the development of posterior capsule opacification (pco) between eyes with and without a history of diabetes mellitus (dm) after single-piece hydrophobic acrylic intraocular lens (iol) implantation 4 years postoperatively.diabetes mellitus would not increase the incidence of pco at 4 years.

there is a paucity of available literature that prospectively evaluates the development of pco with the single-piece hydrophobic acrylic iol implantation in diabetic versus non-diabetic eyes on a long-term basis. therefore, this study was designed to compare the degree of pco after cataract surgery between diabetic and age-matched non-diabetic patients. this prospective, observational case control study comprised patients who underwent phacoemulsification .the patients were asked to return for postoperative follow-up visits at 1 month, 1 year and 4 years. the digital images were analyzed for pco .

Eligibility criteria:
inclusion criteria: * diabetes mellitus was defined as glycosylated haemoglobin (hb a1c ) levels of 6% or more , * use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes. * patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes). exclusion criteria: * patients with glaucoma, * high myopia (axial length \> 27.0 mm), * pseudoexfoliation, * traumatic cataract, * subluxated cataract, * previous ocular surgeries, * allergy to dilating drops.

Keywords: diabetes,posterior capsule opacification,case control study
vitamin d status after single oral dose of cholecalciferol in low fat meal compared to high-fat meal

Conditions: Deficiency, Vitamin D

Summary: the purpose of this study is to evaluate the absorption of dietary supplement of vitamin d3 (cholecalciferol), through the variation of 25 (oh) d levels, as the fat content of the meal associated with the administration of the supplement.

clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin d supplement. participants were randomly in two groups according to sex and bmi. in the same date, each group of participants received a meal and dietary supplement of vitamin d3 (cholecalciferol) after the first blood sample and a urine sample. others samples were collected in the seventh and fourteenth day after intake the supplement.

Eligibility criteria:
inclusion criteria: * residents of the hospital clinics of porto alegre exclusion criteria: * don't drink milk * obesity * malnutrition * liver disease * kidney disease or diabetes * use of dietary supplements containing calcium and vitamin d * medications * anticonvulsants * barbiturates, or steroids. * having performed a journey the last four months to locations near the earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.

Keywords: vitamin d colecalciferol absorption by vitamin d
safety and efficacy study of rt001 to treat moderate to severe lateral canthal lines

Conditions: Lateral Canthal Lines

Summary: the purpose of this study is to determine the safety and efficacy of 2 sequential doses of rt001 compared to vehicle control following applications at baseline (day 0) and week 2.

this is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of rt001 in at least 30 subjects with moderate to severe lateral canthal lines. subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (rt001 dose a or vehicle control).

Eligibility criteria:
inclusion criteria: 1. female/male ages 30 to 55 2. bilateral lateral canthal lines rated as moderate or advanced. 3. willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through week 6. 4. women of child baring potential must practice and be willing to continue to use an effective method of birth control. exclusion criteria: 1. muscle weakness or paralysis in the area receiving treatment. 2. active skin disease or irritation at treatment areas. 3. undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening. 4. previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to baseline (day 0). 5. use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through end of study (week 6). 6. any abnormality on the electrocardiogram (ecg) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.

Keywords: lateral canthal lines crow's feet facial wrinkles lateral canthal area
visceral stiffness measurement using acoustic radiation force impulse

Conditions: Visceral Stiffness; Liver Fibrosis

Summary: the acoustic radiation force impulse (arfi) technology provides real-time measurements of tissue stiffness. aim: using the arfi ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral arfi quantification and the referenced metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.

using arfi technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire metavir fibrosis scoring and various functional stratifications.

Eligibility criteria:
inclusion criteria: * patients with chronic liver diseases who underwent liver biopsy * patients with pathologically or radiologically proven cirrhosis exclusion criteria: * post major abdominal surgery * after interferon or neucleos(t)ides treatment * pbc,psc,wd,aih,viral coinfections * liver abscess * exposure to hepatotoxic drugs or chemicals * thrombosis of splenic vein, portal veins * after resection or embolism of the spleen * acute or chronic pancreatitis * biopsy contraindications (not exclusive) * arfi measurements low quality * fibrotest contraindications: acute hepatitides, extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, cbd\>0.7cm severe hemolysis * cardiac congestion * liver cancer other than hcc * treated hcc
gut microbiota, the potential key to modulating humoral immunogenicity of new platform covid-19 vaccines

Conditions: Microbiome; Vaccine; Covid-19; SARS-CoV-2; Immunogenicity

Summary: vaccination is the best way to mitigate the coronavirus disease 2019 (covid-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. there is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. thus, the investigators investigated the relationship between gut microbiota and humoral immune response after covid-19 vaccination.


Eligibility criteria:
inclusion criteria: * people assigned to get either bnt162b2 or chadox1 vaccines * informed concents exclusion criteria: * participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.
implementation of a clinical decision support tool for postpartum depression

Conditions: Postpartum Depression

Summary: this study will evaluate the use of an automated process in the electronic health record (ehr) that will help providers to detect patients at risk of developing postpartum depression (ppd).

the goal of this randomized clinical trial is to assess the implementation of a clinical decision support (cds) tool. the tool is designed to assist providers in managing patients at risk of developing of postpartum depression. investigators hypothesize that this tool will be acceptable and feasible for use and improve the use of mental health services for postpartum depression. patients in the control arm will receive usual care, while those in the intervention arm will receive cds. clinicians will manage patients per usual care, including initiating ppd preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. clinicians in the intervention arm will refer patients based on the cds.

Eligibility criteria:
inclusion criteria: * 18 years or older * being seen at one of participating clinics * pregnancy at 20 week gestation or more exclusion criteria: * does not speak inclusion * does not have internet access clinician eligibility: * if they manage patients in the three clinics as a board-certified obgyn clinician. * no exclusion criteria apply for clinician based on their knowledge and experience in treating ppd

Keywords: clinical decision support tool
perioperative duloxetine for pain management after laparoscopic hysterectomy

Conditions: Laparoscopic Hysterectomy; Postoperative Recovery; Postoperative Pain

Summary: the aim of the investigators of the study is to evaluate the effect of peri-operative duloxetine on post-operative recovery in patients undergoing laparoscopic hysterectomy.

patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study. after randomization, the study participants will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery, whereas the control participants will be given placebo tablets.

Eligibility criteria:
inclusion criteria: * patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study exclusion criteria: * patients with chronic non-gynecologic conditions (liver or pulmonary disease, diabetes), using psychiatric drugs (anti-depressants, neuroleptics, lithium) in the last 1 year, those with duloxetine allergy, and patients using opioids for gynecologic or non-gynecologic conditions will be excluded from the study.

Keywords: duloxetine laparoscopic hysterectomy postoperative pain postoperative recovery
a study to evaluate the safety and efficacy of ex vivo expanded autologous immune killer cells (ikc) in stage iv non-small cell lung cancer (nsclc) in patients who failed chemotherapy or target therapy

Conditions: Non-small Cell Lung Cancer (NSCLC) Stage IV

Summary: in this study, whole blood is drawn from the patient to be used to grow immune killer cells (ikc). after proliferation, the ikc will be infused back into the patient to treat the cancer for a total of 24 weekly treatments. possible adverse reaction can include slight fever and headache.


Eligibility criteria:
inclusion criteria: 1. age≧20 years old 2. life expectancy≧3 months 3. eastern cooperative oncology group (ecog) score 0\~2 4. cytologically-or histologically-confirmed non-small cell lung cancer（nsclc) 5. patients with clinical tnm classification of malignant tumours (tnm) stage iv... exclusion criteria: 1. patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period 2. patients with hiv, htlv or active tuberculosis 3. women who are pregnant or breast-feeding 4. patients with drug or other substance abuse 5. patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)

Keywords: immune cell therapy ikc